Non-Hodgkin's Lymphoma Clinical Trial
Official title:
A Multicenter, Double-Blind, Randomized Study of Pegfilgrastim Administered on the Same Day or the Next Day of R-Chop Chemotherapy in Subjects With Non-Hodgkin's Lymphoma
The purpose of this study is to provide data on the safety and efficacy of pegfilgrastim when administered on the same day versus the next day of chemotherapy, as measured by the duration of grade 4 neutropenia.
This was a multicenter, double-blind, randomized, phase 2 study of pegfilgrastim given
either the same day as or the day after a chemotherapy regimen consisting of
cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (R-CHOP).
Chemotherapy was administered every 21 days for up to 6 cycles in subjects with aggressive
non-Hodgkin's lymphoma (NHL; mantle cell or diffuse large B-cell lymphoma). Subjects were
administered R-CHOP on day 1 of each cycle. All subjects were randomized to 1 of 2 treatment
arms: arm A subjects were administered pegfilgrastim 6 mg on day 1 of each cycle (within 4
hours of chemotherapy completion); arm B subjects were administered pegfilgrastim 6 mg on
day 2 of each cycle (at least 24 hours after chemotherapy completion). All subjects were
administered placebo on the day they did not receive pegfilgrastim. A total of 77 subjects
were enrolled at 24 centers across the US. Protocol treatment duration for subjects was up
to 18 weeks (6 three-week cycles).
;
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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